ID
35826
Descrição
Study ID: 110028 Clinical Study ID: 110028 Study Title: Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00510874 https://clinicaltrials.gov/ct2/show/NCT00510874 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine Trade Name: Pumarix, Pandemrix Study Indication: Influenza This study consists of 6 Visits and one Telephone Contact: -Visit 1: Visit „Day 0“ -Visit 2: Visit „Day 7“, Contact Window: Day 6-8, Minimum Number of Days between Successive Visits: 6 -Visit 3: Visit „Day 21“: Contact Window: Day 19-23, Minimum Number of Days between Successive Visits: 12 -Visit 4: Visit „Day 28“: Contact Window: Day 26-30, Minimum Number of Days between Successive Visits: 6 -Visit 5: Visit „Day 42“: Contact Window: Day 38-46, Minimum Number of Days between Successive Visits: 12 -Telephone Contact „Day 84“: Contact Window: Day 80-88 -Visit 6: Visit „Day 182“: Contact Window: Day 167-197 The screening can take place up to 21 days prior to Visit 1. This document contains the Non-serious AE form. At each study visit / contact the investigator should question the subject about any occurrence of AE. All AEs occurring within 21 days following administrations of the two dose of vaccine must be recorded on the Adverse Event form in the subject's CRF, irrespective of intensity or whether or not they are considered vaccinationrelated. Throughout the entire study period, AEs related to new onset chronic diseases must be recorded on the Adverse Event form in the subject’s CRF irrespective of severity or whether they are considered vaccination-related. In order to be characterized as a NOCD, an AE should be: -Absent at baseline evaluation and absent from the medical history, -Unresolved, and not anticipated to resolve, at the time of study termination, and -Likely, in the investigator’s opinion, to require chronic medical care or monitoring to manage an active disease process.
Link
https://clinicaltrials.gov/ct2/show/NCT00510874
Palavras-chave
Versões (1)
- 25/03/2019 25/03/2019 -
Titular dos direitos
GlaxoSmithKline
Transferido a
25 de março de 2019
DOI
Para um pedido faça login.
Licença
Creative Commons BY-NC 3.0
Comentários do modelo :
Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.
Comentários do grupo de itens para :
Comentários do item para :
Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.
Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine in Adults, NCT00510874
Non-Serious Adverse Events (AE)
- StudyEvent: ODM
Similar models
Non-Serious Adverse Events (AE)
- StudyEvent: ODM
C0237753 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
C0746890 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
C0205253 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,4])
C0877248 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,4])